The U.S. Food and Drug Administration (FDA) recently rejected Fontem’s premarket application for Blu PLUS+ brand e-cigarette products.
"It is FDA's regulatory responsibility to conduct scientific reviews of tobacco products," said Brian King, director of the FDA's Center for Tobacco Products. "It is the applicant's responsibility to ensure that sufficient scientific evidence is included in the application to meet the necessary public health standards required by law. We believe Fontem lacks such evidence."
Fontem is not allowed to sell these products in the United States or face penalties from the FDA. The company said it may submit new applications for the rejected products.